- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04824833
Effects of US-guided SAPB During Breast Surgery
The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study
The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.
We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey, 67600
- Zonguldak Bülent Ecevit University Medicine Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between the ages of 18-75,
- ASA I-II-III risk group
- Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
- Patients whose informed consent was read and whose consent was obtained
Exclusion Criteria:
- who do not want to participate in the study,
- ASA IV-V patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Active Comparator: Serratus anterior plane block
|
local anesthetic application between serratus anterior muscle and 5th rib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemodynamic stability
Time Frame: during surgery
|
effect of serratus anterior plane block on hemodynamic stability during breast surgery
|
during surgery
|
opioid consumption
Time Frame: during surgery
|
effect of serratus anterior plane block on opioid consumption during breast surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
emergence time
Time Frame: end of the surgery
|
the time period between surgical incision closure and extubation.
|
end of the surgery
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/03-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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